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Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection

NCT00485134 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2017-09-11

Study results available
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Summary

The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea, dysentery, and fever following challenge with the Shigella flexneri 2a 2457T strain.

Conditions

  • Shigellosis

Interventions

BIOLOGICAL

240 µg Shigella flexneri 2a Invaplex 50 vaccine

Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

BIOLOGICAL

480 µg Shigella flexneri 2a Invaplex 50 vaccine

Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

BIOLOGICAL

690 Shigella flexneri 2a Invaplex 50 vaccine

Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

OTHER

Shigella challenge strain

300 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T

Sponsors & Collaborators

  • U.S. Army Office of the Surgeon General

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Mark Riddle, MD · Naval Medical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-07-31
Completion
2010-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00485134 on ClinicalTrials.gov